ISO 18192-1 Wear Testing for Intervertebral Disc Prostheses
The ATS FoC operates a proven medical device testing lab to ensure manufacturer compliance with international standard ISO 18192-1 for artificial intervertebral discs. Total intervertebral discs are motion-preserving implants designed to stabilize the spinal column, relieve excess pressure on the surrounding vertebrae, and permit the user to continue daily activities.
ISO 18192-1 Requirements
Before approving a product for clinical trials, the FDA requires manufacturers to prove a product can provide the support needed while withstanding the environmental loads and conditions of the spinal cavity. The ATS FoC offers strict medical device testing that follows industry-recommended best practices and international testing procedures. ISO 18192-1 is an FDA-recognized standard for comparing the performance of cervical and lumbar spinal implants.
Wear Test Procedure
To simulate an intervertebral disc’s daily movements, our experts place the product in a testing apparatus designed to recreate spinal flexion/extension, lateral bending, and axial rotation motions. Throughout the test, the product undergoes axial compression at a 1 Hz frequency while soaked in a calf serum diluted with de-ionized water. The test continues until the product reaches the 10 million cycle limit or fails.
Our experts use gravimetric analysis to measure an implant’s weight and height loss due to wear. If needed, ATS can support our analysis with Scanning Electron Microscopy (SEM) and particle analysis.
About ATS FoC
The ATS Family of Companies provides medical device testing from multiple ISO/IEC 17025:2017 accredited labs. To help clients reach the market faster, our qualified experts use innovative technology and follow proven best practices for quick and efficient testing. We offer additional support through our four pillars of service: consulting engineering, calibrations, testing, and inspections.
Call +1 (888) 287-5227 or complete the form on this page to request medical device testing from the ATS FoC.
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Medical Device Testing
ASTM Testing
- ASTM F1044 Shear Testing of CaP and Metallic Coatings
- ASTM F1160 Shear and Bending Fatigue of Coatings
- ASTM F1264 Intramedullary Fixation Device Testing
- ASTM F1357 Articulating Total Wrist Implant Testing
- ASTM F1378 Shoulder Prostheses Testing
- ASTM F1541 ESFD Testing
- ASTM F1672 Patellar Prosthesis Testing
- ASTM F1714 Gravimetric Wear Assessment of Prosthetic Hip Design in Simulator Device Testing
- ASTM F1717 Spinal Implant Testing
- ASTM F1781 Elastomeric Flexible Hinge Finger Total Joint Implants Testing
- ASTM F1798 Spinal Implant Subassembly Testing
- ASTM F1820 Modular Acetabular Device Strength Testing
- ASTM F1829 Glenoid Locking Mechanism Shear Testing
- ASTM F1875 Fretting Corrosion Testing of Hip Implant Interfaces
- ASTM 2009 Modular Prostheses Taper Connection Testing
- ASTM F2025 Wear Assessment of Polymeric Components
- ASTM F2028 Glenoid Loosening Testing
- ASTM F2077 Intervertebral Body Fusion Device Testing
- ASTM F2183 Small Punch Testing
- ASTM F2193 Spinal Fixation Components
- ASTM F2267 Measuring Subsidence of Intervertebral Fusion Devices
- ASTM F2346 Standard and Dynamic Testing of Artificial Intervertebral Discs
- ASTM F2423 Wear and Fatigue Testing of Total Disc Prostheses
- ASTM F2502 Absorbable Plate and Screw Testing
- ASTM F2554 CAS System Precision Testing
- ASTM F2624 Static, Dynamic, and Wear Testing of Extra-Discal Spinal Implants
- ASTM F2624 Spinal Implant Dynamic Testing
- ASTM F2694 Lumbar Total Facet Prosthesis Testing
- ASTM F2706 Spinal Implant Fatigue Testing
- ASTM F2789 Mechanical and Functional Characterization of Nucleus Devices
- ASTM F2790 Static and Dynamic Testing of Total Facet Prostheses
- ASTM F382 Metallic Bone Plates Testing
- ASTM F384 Angled Orthopedic Fixation Testing
- ASTM F543 Metallic Medical Bone Screw Testing
- ASTM F564 Metallic Bone Staple Testing
ISO Testing
- Biocompatibility Testing for Medical Devices ISO 10993
- ISO-10328 Structural Testing of Lower Limb Prosthetics
- ISO 10993 Biocompatibility
- ISO 10993 Biocompatibility Testing
- ISO 10993 Testing
- ISO 10993 Testing Lab
- ISO 18192-1 Wear Testing for Intervertebral Disc Prostheses
- ISO 12189 Fatigue Testing of Flexible Spinal Implants
Medical Device Testing
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